Biotech therapeutics company Awakn Life Sciences Corp. (OTCQB:AWKNF) will receive funding from national agency Innovate UK destined to identifying the quickest and most cost-effective route to market in the UK and the US for Awakn's lead program: proprietary ketamine-assisted therapy for treating alcohol use disorder (AUD).
The initiative is led jointly by the Centre for Process Innovation (CPI) and the Association of British HealthTech Industries (ABHI).
Awakn will work with Veristat, a global clinical research organization specialized in accelerating therapies through clinical development towards regulatory approval and commercialization.
“This funding enables Awakn, working closely with Veristat, to bring a much-needed effective treatment approach to the market as soon as possible,” the company’s chief scientific officer, Shaun McNulty stated. “Delivering this innovative therapeutic approach as rapidly as possible to patients in the UK and the US is critical to address this major unmet medical need."
CEO Anthony Tennyson affirmed that Innovate's UK funding “is a major endorsement of our efforts and approach to developing new and effective treatments for addictions.”
The company’s lead program, Project Kestrel, aims to deliver marketing authorization/regulatory approval for ketamine-assisted therapy to treat AUD in both the UK and the US with clear Intellectual Property (IP) surrounding the treatment.
The program builds on Awakn's successful Phase II a/b 'KARE' clinical trial and efficacy data released in January 2022, which demonstrated ketamine-assisted therapy’s safety and efficacy as a new treatment option for AUD patients.
The trial resulted in patients experiencing on average 86% abstinence at 6 months post treatment versus 2% before the trial, which translates to participants going from being sober on average 7 days a year to being sober on average 314 days a year.
The company intends to begin a Phase III trial in the UK in 2022 and another one in the US thereafter. The studies are designed to provide the key data that would bring Project Kestrel to market as quickly as possible.
Awakn has also applied for a grant to the UK's National Institute for Health and Care Research (NIHR) to cover two-thirds of the cost of the planned Phase III trial. The decision on this application will be announced shortly.
The outputs from Project Kestrel will benefit the company’s R&D project portfolio by defining a clear regulatory pathway for drug-assisted therapies to treat not only AUD but also other behavioral addictions for which Awakn is developing therapies.
